ARCHIVED Authorized medical devices for uses related to COVID-19: Overview

Notice to Reader:

This is an archived page. Find information on the authorization of medical devices for an urgent public health need.

Find information about exceptional import and sale of medical devices:

• List of medical devices for exceptional import and sale
• Guidance for exceptional import and sale of medical devices

On this page

• How to identify authorized COVID-19 medical devices
• Understanding the lists of authorized medical devices

How to identify authorized COVID-19 medical devices

In addition to existing medical device databases, there are lists of authorized COVID-19-related medical devices.

The following information explains what resources to check to determine if a medical device has been licensed or authorized in Canada.

Class I devices (such as masks, respirators, eye protection, gowns and swabs)

Class I medical devices can be imported or sold according to one of 4 possible mechanisms:

• the manufacturer or importer holds a Medical Device Establishment Licence (MDEL)
• the device is included in the list of authorized medical devices other than testing devices
• the device is included in the list of medical devices for expanded use in relation to COVID-19
• the device is included in the list of medical devices for exceptional importation and sale

Class II, III and IV devices (such as gloves, ventilators and testing devices)

Class II, III and IV medical devices can be imported or sold according to 1 of 5 possible mechanisms:

• the device is included in the Medical Devices Active Licence Listing
• the device is included in the list of authorized testing devices
• the device is included in the list of authorized medical devices other than testing devices
• the device is included in the list of medical devices for expanded use in relation to COVID-19
• the device is included in the list of medical devices for exceptional importation and sale

Understanding the lists of authorized medical devices

Medical device establishment licences

Class I devices can be imported or manufactured without an authorization under Part 1.1 of the Medical Devices Regulations (MDR) if the manufacturer or importer holds a medical device establishment licence (MDEL). Consult the list of active MDELs to see whether a company is authorized to import or sell Class I medical devices. Most personal protective equipment (PPE), with the exception of medical gloves, are Class I devices.

Medical device licences

Class II, III and IV devices are licensed in accordance with the MDR. Consult the Medical Devices Active Licence Listing to see whether a Class II, III or IV device is licensed under the regulations. Certain gloves and ventilators that can be used for COVID-19 are licensed devices.

List of authorized testing devices

Only testing devices authorized by Health Canada can be imported or sold in Canada. Testing devices on this list are authorized under Part 1.1 of the MDR.

Testing devices for COVID-19 contains more information on different types of testing devices that Health Canada is authorizing.

For information on how to obtain an authorization, consult the following guidance document:

• Medical devices for use in relation to COVID-19

List of authorized medical devices other than testing devices

Devices that are on this list are authorized under Part 1.1 of the MDR.

For information on how to obtain an authorization, please consult the following guidance document:

• Medical devices for use in relation to COVID-19

List of medical devices for expanded use in relation to COVID-19

Some medical devices have been granted an expanded use in relation to COVID-19. These devices carry diagnostic, treatment, mitigation or prevention claims in relation to COVID-19 based on known evidence.

Health Canada maintains the list and will update it as required. The list is incorporated by reference in the MDR.

To access the latest version of the list, please refer to:

• List of Medical Devices for Expanded Use in Relation to COVID-19

For information on how medical devices are granted an expanded use indication in relation to COVID-19, please consult the following guidance document:

• Medical devices for use in relation to COVID-19

List of medical devices for exceptional importation and sale

Certain devices may not fully meet regulatory requirements, but are manufactured according to comparable standards. These may be included on the list of medical devices for exceptional importation and sale when the Canadian-approved product is in shortage. They are eligible under the provisions in the MDR that came into force on March 2, 2022. Products missing device identifiers or products that do not have English and French labelling are examples of medical devices that may be eligible for this pathway.

Health Canada maintains the list of medical devices for exceptional importation and sale, which is incorporated by reference, and will update it as required. The list includes devices first permitted under the Interim Order respecting drugs, medical devices and foods for a special dietary purpose in relation to COVID-19 (March 30, 2020, to February 28, 2021) and the Second Interim Order respecting drugs, medical devices and foods for a special dietary purpose in relation to COVID-19 (made on March 1, 2021, to  March 1, 2022).

For more information on how medical devices are included on this list, please consult:

• Guidance for exceptional import and sale of medical devices